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Application for Drug Safety Certification
Appoint a Drug Consultant
For drug safety certification, hire a consultant for error-free registration.
Send Documents
Email the required legal documents to our professionals. They attach them to the drug license application form.
Certificate Verification
The documentation by applicants will be reviewed by our expert team before attaching it to the application form.
Drug Certificate Approval
Our team confirms the drug license approval notification via SMS or email.
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Drug License (Retail/Wholesale) Registration
Under the act of Drugs and Cosmetics Act, getting the drug safety certification in India is a critical step. The arrangements for this have been made in the Drugs & Cosmetics Act, 1940, which applies to the entire India for manufacturers, distributors, and importers. It is an act to combine all the laws relating to drugs & cosmetics, which set up the Drugs Control Department. Anyway, a selected business entity may require distinctive forms of drug licenses online apply based on their enterprise; you may get in touch with LegalRaasta for consultancy on it.
If a business functions in several states, in that case, it must obtain a separate drug certificate for each state where it carries out its activities, as drug safety certifications are location-specific. If drugs are sold or distributed for sale at multiple locations, a separate application must be submitted and a pharmacy license issued for each premises, except in the case of itinerant vendors. Additionally, depending on the nature of the drugs being handled, a CDSCO certificate may also be required to comply with central regulatory norms.
The Purpose of Drug License Registration
Securing the drug certificate in India signifies a legal requirement. Under the Drugs and Cosmetics Act, 1940, the manufacturers, retailers, wholesalers, and importers are required to register with the CDSCO for a drug license. The major purpose was to introduce the rules and regulations to provide market access to drug business operators. The wholesale drug license registration is the process to align with regulatory compliance to ensure product safety and quality.
Although no single drug business operator is allowed to regulate the pharmaceutical sector without a license. Overall, with a pharmacy license apply online, businesses and individuals get the permission to engage in the drug market legally. The certificate signifies that the entities are aligning with regulatory compliance. It is important to protect the patients from expired or hazardous products.
Types of Drug Licenses in India
The governing authority, CDSCO, introduced the multiple drug license online apply based on the business nature. The types of drug certificates are:
Wholesale Drug License (WDL)
The wholesale drug license in Delhi is required when the business distributes in bulk quantities to other retailers or hospitals.
Retail Drug License (RDL)
Pharmacies or medical stores in connection with drug consumers are required to apply for a retail drug license registration.
Manufacturing Drug License (MDL)
The business that manufactures the drug or cosmetics needs to obtain the manufacturing drug certificate.
Import License
The businesses that import medicines and their raw substances in India, required to register for an import license with the CDSCO.
Export License
This license is needed when a business exports drugs or pharmaceutical products.
Loan License
It is obtained by the drug manufacturers who utilize the facility of a registered licensed manufacturer (contract manufacturing).
Multi-Drug License
Businesses engaged in the drug trade across multiple states in India under the same organizational name are required to secure a multi-drug license.
What is Included In Our Package?
Technical
Support
Expert
Consultation
Documentation
Preparation
Documents
Drafting
Drug form
filing
Government
Fees
Prepare for
inspection
Required Documentation for Drug License Registration
Gather the documents related to the premises, applicant, and any relevant personnel. The essential required documents are:
Applicant Information
Affidavit of Proprietor/Partner/Director
Certificates of Educational Qualification
Photo ID proof
Proof of applicant's residence
Premise Information
Proof of evidence of ownership
The ownership documents
Detailed layout of premises
Premise connectivity proof (Electricity or water bill)
Other Documents
Experience Certificate
Proof of registration
Cover letter
Form 19/ Form 19C
No Objection Certificate (NOC), if applicable
The blueprint of the Premises
Steps for Getting the Drug Certificate or Drug License
To obtain the drug license, apply online to the relevant state drug control authority.
Step 1: Select License Type
As per your drug business nature, choose the right license type ( e.g, retail, manufacturing, wholesale, or import)
Step 2: Collect Necessary Documents
Gather the documents like proof of ownership, application forms, certificate copies, and many others. The drug control authority must specify the other documents.
Step 3: Online Application
Choose the online application mode for drug license registration. Every state of India has an online application portal where applicants register.
Step 4: Mandatory Fee
Pay the mandatory government fee online and keep a copy of the Challan/Payment receipt.
Step 5: Application Submission
Submit the drug license application form with the necessary documents.
Step 6: Inspection by CDSCO
The officials of CDSCO may conduct a premises inspection to ensure compliance with regulations.
Step 7: Drug License Approval
The State Drug Control Authority will issue the drug license after the application review and inspection.
Eligibility Criteria to Obtain a Drug Certificate
Technical Staff
The staff of a retail pharmacy must be knowledgeable in the relevant field. They must have 1 year of pharmacy field experience and have a graduation degree. If you are an undergraduate, you must have four years of experience.
Storage Facility
Most of the medicines are required to be stored at a certain temperature or a low temperature. The drug businesses must have the facility of pharmaceutical product storage, like refrigerators and air conditioners.
Premise Requirements
The pharmacy or the unit area must not exceed 15 square meters. This category is fixed for both retail and wholesaler license recipients. The height of the unit must align with the guidelines of the National Building Code of India, 2005.
Qualified Personnel
The applicant for the drug register is required to possess a degree in B. Pharm or D. Pharm. To obtain a wholesale drug license, the applicant must hold a graduation degree along with at least one year of experience, or if they are an undergraduate, they must have four years of experience.
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